Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging
We propose a single-scan two-injection myocardial perfusion imaging protocol using ammonia. Subjects will undergo single-scan two-injection imaging as well as regular stress single-scan single-injection protocol and the myocardial blood flow of both techniques will be compared.
Conditions:
🦠 Coronary Artery Disease 🦠 Myocardial Ischemia
🗓️ Study Start (Actual) 21 September 2017
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 60
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

  • Healthy Volunteers:
  • Inclusion Criteria:

    • * Subjects must be ≥30 and ≤75 years of age;
    • * Subjects must provide informed consent prior to study procedures;

    Exclusion Criteria:

    • * History of CAD, including:
    • * Prior abnormal myocardial perfusion study
    • * History of MI
    • * History of angina
    • * Coronary artery obstruction \>50% on CTA and/or angiography
    • * Left ventricular ejection fraction \<50%
    • * Any relative or absolute contraindication to adenosine stress, including:
    • * 2nd or 3rd degree heart block
    • * Bradycardia (HR\<50 bpm)
    • * Recent acute coronary syndrome (ACS)
    • * Unstable angina
    • * Severe heart failure (left ventricular ejection fraction \<15%)
    • * Ventricular arrhythmia
    • * Severe asthma and/or chronic obstructive pulmonary disease (COPD)
    • * Baseline hypotension defined as systolic blood pressure \< 90 mmHg
    • * Caffeine intake within 24 hours prior to imaging
    • * Current use of theophylline, dipyridamole, or carbamazepine
    • * Allergy or intolerance to adenosine
    • * Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
    • Subjects with CAD:
    • Inclusion criteria
    • * Subjects must be ≥30 and ≤75 years of age;
    • * Subjects must provide informed consent prior to study procedures;
    • * Abnormal myocardial perfusion study within the past 12 months
    • Exclusion criteria
    • * Revascularization (percutaneous coronary intervention and/or coronary artery bypass) following last myocardial perfusion study
    • * Acute coronary syndrome within 30 days
    • * Left ventricular ejection fraction \<50%
    • * Any relative or absolute contraindication to adenosine stress, including:
    • * 2nd or 3rd degree heart block
    • * Bradycardia (HR\<50 bpm)
    • * Recent acute coronary syndrome (ACS)
    • * Unstable angina
    • * Severe heart failure (left ventricular ejection fraction \<15%)
    • * Ventricular arrhythmia
    • * Severe asthma and/or chronic obstructive pulmonary disease (COPD)
    • * Baseline hypotension defined as systolic blood pressure \< 90 mmHg
    • * Caffeine intake within 24 hours prior to imaging
    • * Current use of theophylline, dipyridamole, or carbamazepine
    • * Allergy or intolerance to adenosine
    • * Any clinically significant acute or unstable physical or psychological disease, judged by the investigators, to be incompatible with the study;
    • * Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
    • * Female participants only: Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
    • * Inability to provide written informed consent;
Ages Eligible for Study: 30 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 August 2017
  • First Submitted that Met QC Criteria 25 August 2017
  • First Posted 29 August 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 April 2023
  • Last Update Posted 13 April 2023
  • Last Verified April 2023